With more available tests and less stringent clinical criteria for testing, the U.S. could have set up a more proactive system for detecting coronavirus cases, although it’s possible the outcome would still be the same.
The CDC, in fact, wanted to set up a five- or six-site surveillance network in cities such as Los Angeles, San Francisco, Seattle, Chicago and New York City, which would begin testing for COVID-19 in people with flu-like symptoms who test negative for influenza. The plan was to then scale up the network to each state. But with the test kit difficulties, that schedule was set back. On Feb. 28, the CDC said that it expected to have the first of six sites up and running by the following week. When we asked on March 10, the agency did not have an immediate update on the program.
How many tests are available?
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Part of the confusion has to do with the fact that testing is happening at several different levels — by the CDC, by state and local public health labs, and at hospitals and other facilities — and that the words used to describe the testing aren’t always consistent.
A test “kit” means an entire box of supplies to run tests to diagnose many people. A CDC test kit, for example, is able to test 700 to 800 specimens. Other test kits come with enough reagents for 500 “reactions.” Because controls need to be run, fewer than 500 samples can be tested with such a kit. And in both cases, the actual number of people who could be diagnosed with each will be lower, since patients may have multiple samples or samples may be run in duplicate. The same issue applies to the word “test.”
FDA Commissioner Stephen Hahn provided the clearest answer about testing capacity on March 7, when he said that the CDC had shipped enough kits to state and local public health labs to test 75,000 people for COVID-19.
In addition, more than 1.1 million tests manufactured by Integrated DNA Technologies had been shipped as of March 6 for non-public health labs to use, with another 400,000 possibly shipping by March 9. A separate manufacturer had also produced 640,000 tests that could have shipped as early as March 9, once quality control testing was complete.
“The actual number of tests that have shipped is larger than the number of patients that can be tested,” Hahn explained, noting that the approximately 2.1 million tests from IDT and another company would allow roughly 850,000 Americans to be tested.
On top of those tests, he added, would be any testing by commercial or academic labs, plus an expected additional 4 million tests from IDT and the other company by the end of this week. The CDC itself also can test approximately 350 specimens per day.
In a March 9 telebriefing, the CDC’s Nancy Messonnier clarified that the 75,000 people that can be tested using the CDC’s test kit in public health labs is a cumulative figure. She also said that in the coming weeks, as more manufacturers join the effort, the “majority” of testing will be from the commercial sector.
Several commercial companies have stepped forward to increase production. Quest Diagnostics said it could begin testing on March 9, and LabCorp said its test was available for ordering on March 5, with results taking three to four days once a specimen is received in the mail.
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